Pure Global

BREG Tri Panel Knee Immobilizer (Regular & Deluxe) - Indonesia BPOM Medical Device Registration

BREG Tri Panel Knee Immobilizer (Regular & Deluxe) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11402220100. The device is manufactured by BREG MEXICO S. DE R.L. DE C.V. from Mexico, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. ORTHOCARE INDONESIA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : A
BREG Tri Panel Knee Immobilizer (Regular & Deluxe)
Analysis ID: AKL 11402220100

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

Mexico

Authorized Representative

PT. ORTHOCARE INDONESIA

AR Address

RUKO GALERI NIAGA MEDITERNIA 2 BLOK N 8 J , JL.PANTAI INDAH UTARA II RT/RW : 007/008 KEL KAPUK MUARA KEC. PENJARINGAN KOTA ADM JAKARTA UTARA

Registration Date

Apr 13, 2022

Expiry Date

Dec 31, 2025

Product Type

Prosthetic Physical Health Equipment

Prosthetic and orthotic accessory.

Non Electromedic Non Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing